Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

July 28, 2013 updated by: Kazuhiko Okuyama, MD, Ibaraki Children's Hospital

The Effect of Small-dose Ketamine on Depression of Respiratory and Cardiac Functions Caused by Propofol in Pediatric Cardiac Catheterization

Normal cardiac and respiratory functions should be maintained during pediatric cardiac catheterization. Propofol has become a popular choice for sedation in children, however, it depresses cardiac and respiratory functions. Some investigators reported that ketamine attenuates its depressant effect, but it remains unclear whether ketamine reduces cardiac and respiratory depression caused by propofol in pediatric cardiac catheterization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Ibaraki
      • Mito, Ibaraki, Japan, 311-4145
        • Ibaraki Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 7kg-25kg (6mo-10yrs) children who undergo cardiac catheterization

Exclusion Criteria:

  • patients who have neurological disease,
  • endocrinological disease,
  • airway anomaly, who require positive pressure ventilation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: control
propofol and saline are administered
Drug: control
propofol 8mg/kg/h saline 0.24 ml/kg/h
Other Names:
  • saline with propofol
EXPERIMENTAL: Ket10
ketamine is co-administered with propofol
Drug: Ket10
propofol 6.4 mg/kg/h ketamine 10 microg/kg/min
Other Names:
  • ketamine 10 γ
EXPERIMENTAL: Ket20
ketamine is co-administered with porpofol
Drug: Ket20
propofol 4.8 mg/kg/h ketamine 20 microg/kg/min
Other Names:
  • ketamine 20 γ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference of end tidal partial pressure of carbon dioxide between the groups
Time Frame: 30 and 60 min after anesthetic induction
30 and 60 min after anesthetic induction
difference of partial pressure of arterial carbon dioxide between the groups
Time Frame: 60 min after anesthetic induction on average
60 min after anesthetic induction on average
heart rate change from baseline value
Time Frame: 30 and 60 min after anesthetic induction
30 and 60 min after anesthetic induction
non-invasive blood pressure change from baseline value
Time Frame: 30 and 60 min after anesthetic induction
30 and 60 min after anesthetic induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
movement at topical anesthetic injection
Time Frame: 20 min after anesthetic induction on average
  1. none (no movement or slight movement unnecessary to restrain)
  2. mild (movement necessary to restrain, limited to lower extremities)
  3. moderate (strong movement of lower extremities and movement of upper extremities unvecessary to restrain)
  4. severe (movement necessary to restrain upper extremities and body trunk in addition to lower extremities, or some vacalization)
20 min after anesthetic induction on average
the number of times that secreted saliva is aspirated by an attending anesthesiologist
Time Frame: From anesthetic induction to termination of anethetics administration, which is not over 2 hours from anesthetic induction
From anesthetic induction to termination of anethetics administration, which is not over 2 hours from anesthetic induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ibaraki Children's Hospital

Investigators

  • Study Chair: Kazuhiko Okuyama, MD, Ibaraki Children's Hospital
  • Principal Investigator: Yuki Takeda, MD, Ibaraki Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

December 10, 2011

First Submitted That Met QC Criteria

December 26, 2011

First Posted (ESTIMATE)

December 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2013

Last Update Submitted That Met QC Criteria

July 28, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ketamine in sedation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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